Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYongquan Shi
About this trial
This study aims at evaluating efficacy and safety of Saccharomyces boulardii combined with bismuth-containing quadruple Therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Saccharomyces boulardii combined with bismuth-containing quadruple Therapy is superior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18~75, both gender.
Patients who had failed H.pylori eradication therapies .
Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Disqualifiers
Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
Contraindications to study drugs.
Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
Trial design
Design model
Parallel
Treatments tested in this trial
Bismuth
DrugBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
Esomeprazole
DrugBismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 20mg 1 tablets BID plus bismuth 110 mg 2 capsules BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
Tetracycline
DrugBismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
Furazolidone
DrugBismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
Saccharomyces Boulardii Oral Powder
DrugSaccharomyces boulardii combined with Bismuth-containing quadruple therapy:given for 14 days at a dose of Saccharomyces boulardii powder 250 mg 2 packets BID#bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
Treatment groups
1,248 Participants
are divided into 2 treatment groupsGroup A: Saccharomyces boulardii combined with Bismuth-containing quadruple therapyExperimental treatment 5 interventions
Group B: Bismuth-containing quadruple therapyActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Helicobacter pylori eradication
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication
Time frame
28 days after treatmentSecondary outcomes
1
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.
Time frame
14 days of treatment, and 28 days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongquan Shi
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov